UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009835
Receipt number R000011498
Scientific Title Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement
Date of disclosure of the study information 2013/01/27
Last modified on 2021/03/05 15:03:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement

Acronym

The effect of monitoring urinary sodium / potassium ratio with support program

Scientific Title

Randomized trial on the effect of monitoring urinary sodium / potassium ratio with support program on dietary habit improvement

Scientific Title:Acronym

The effect of monitoring urinary sodium / potassium ratio with support program

Region

Japan


Condition

Condition

Hypertensive individuals
Healthy individuals

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the effect of lowering the sodium / potassium (Na/K) ratio on dietary improvement through use of a spot urine monitoring device and a conventional dietary education program.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sodium / potassium ratio in 24-hour urine collections

Key secondary outcomes

1. Sodium excretion and potassium excretion in 24-hour urine collections
2. Blood pressure
3. Dietary habit by survey


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

Monitoring system and the conventional dietary program will be applied for the intervention group. This group will have additional monitoring via measurement of Na/K ratio in casual urine. 7 inch tablet device with dietary education software program will be installed and leaflets with dietary education information will be also handed out.

Interventions/Control_2

Monitoring system and the conventional dietary program will be applied for the intervention group. This group will have additional monitoring via measurement of Na/K ratio in casual urine. Leaflets with dietary education information will be also handed out.

Interventions/Control_3

Conventional dietary improvement program will be applied for the control group. Leaflets with dietary education information will be handed out.

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

69 years-old >=

Gender

Male and Female

Key inclusion criteria

_Healthy and hypertensive individuals
_No change on drugs at least a month for hypertensive individuals
_People who are able to use the device
_People who are able to record the result
_People who are able to participate on 24H urine collection

Key exclusion criteria

_Kidney disease, CVD, DM
_Secondary hypertension
_SBP over 180mmHg, DBP over 110mmHg
_Shift workers
_People who cannot understand the dietary improvement information

Target sample size

162


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyuki Miura

Organization

Shiga University of Medical Science

Division name

Department of Health Science

Zip code


Address

Seta Tsukinowa-chou, Otsu, Shiga

TEL

077-548-2191

Email



Public contact

Name of contact person

1st name
Middle name
Last name Katsuyuki Miura

Organization

Shiga University of Medical Science

Division name

Department of Health Science

Zip code


Address

Seta Tsukinowa-chou, Otsu, Shiga

TEL

077-548-2191

Homepage URL


Email

miura@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Omron Healthcare Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Omron Healthcare Co., Ltd.
Omron Personnel Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

オムロンヘルスケア株式会社本社ビル(京都府)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2012 Year 11 Month 27 Day

Date of IRB

2012 Year 12 Month 25 Day

Anticipated trial start date

2013 Year 01 Month 26 Day

Last follow-up date

2013 Year 03 Month 16 Day

Date of closure to data entry

2013 Year 08 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 15 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 22 Day

Last modified on

2021 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name